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HealthyNCT02822937

Sensitivity of Project: EVO Monitor Cognitive Measurements to Pharmacological Agents

A study testing Methylphenidate, Triazolam and Project: EVO in people with Healthy, run by Akili Interactive Labs, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a study in adults to assess the sensitivity of Project: EVO Monitor cognitive measurements to two short-acting cognitively active pharmacological agents. The participants will receive a placebo, and two pharmacological agents in a randomized order for three in-clinic study days. Read more about this study

Who is it for?
Ages 40 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Methylphenidate, Triazolam and Project: EVO
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
18 participants
Where
1 siteUnited States
Study dates
Jul 2016to Nov 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Age 40-55 at the time of informed consent
  • Ability to follow written and verbal instructions (English).
  • Weight between 140 lbs and 240 lbs.
  • Male and female (Gender-matched).
  • Ability to comply with all the testing and requirements.

Who cannot join

  • Known adverse reaction to study medications.
  • Known non-response or paradoxical response to study medications.
  • Current, controlled (requiring a restricted medication) or uncontrolled, self-reported psychiatric diagnosis with significant symptoms such as post-traumatic stress disorder, psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or anxiety disorder, conduct disorder, attention deficit disorder, autism spectrum disorder, or other symptomatic manifestations that in the opinion of the Investigator that may confound study data/assessments.
  • Current self-reported community diagnosis of cognitive ailments such as dementia, Alzheimer's disease, stroke, traumatic brain injury, or other diseases that in the opinion of the Investigator that may confound study data/assessments.
  • Current diagnosis of severe learning disorder, dyslexia, or dyscalculia.
  • Current subjective complaints of inattention or memory loss.
Show all 25Show fewer
  • Currently undergoing psychotherapy, behavioral therapy, or occupational therapy.
  • Current use of psychotropic medication, prescription or otherwise.
  • Motor condition that prevents game playing, as reported by parent or observed by investigator.
  • Impaired visual acuity, as defined by difficulty reading the informed consent even with corrective lenses.
  • Lifetime history of suspected substance abuse or dependence.
  • Current use (defined as within the last 30 days) of products with nicotine, e.g. cigarettes, chewing tobacco, e-cigarettes, nicotine patch, and nicotine gum.
  • History of seizures (exclusive of febrile seizures), a tic disorder, significant tics, a current diagnosis of Tourette's Disorder.
  • Taken part in a clinical trial within 30 days prior to screening.
  • Diagnosis of or patient-reported color blindness.
  • Regular use of psychoactive drugs that in the opinion of the Investigator may confound study data/assessments.
  • Pregnancy.
  • Currently nursing or breastfeeding.
  • Resting heart rate > 100 beats/min.
  • Systolic blood pressure > 150 mm/Hg.
  • History of cardiac abnormalities.
  • History of glaucoma.
  • Current use of monoamine oxidase inhibitors, HIV protease inhibitors, ranitidine, isoniazid, ketoconazole, itraconazole, nefazodone and other azole-type antifungal agents or any other drugs that are contra-indicated for use with study medications.
  • Any other medical condition that in the opinion of the investigator may confound study data/assessments.
  • Any other medical condition that in the opinion of the investigator prohibits the administration of any study medication.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Clinical Trials of Texas

    San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: A Study to Assess the Sensitivity of Project: EVO Monitor Cognitive Function Measurements to Methylphenidate and Triazolam in Adults 40-55 Years Old

This is a study in adults to assess the sensitivity of Project: EVO Monitor cognitive measurements to two short-acting cognitively active pharmacological agents. The participants will receive a placebo, and two pharmacological agents in a randomized order for three in-clinic study days. During each study day in the clinic, the participants will use Project: EVO Monitor and another cognitive task through the day.

Read the detailed description

This is a study in adults ages 40 to 55 to assess the sensitivity of Project: EVO Monitor cognitive measurements to two short-acting cognitively active pharmacological agents, methylphenidate (MPH) and triazolam (TRZ). The participants will receive a placebo, MPH, and TRZ in a randomized order for three in-clinic study days. All drug administration and cognitive testing will take place in the clinic under medical staff supervision. During each study day in the clinic, the participants will use Project: EVO Monitor and do a short digit symbol substitution task (DSST) 8 times over the day. A minimum of 48 hours will be needed between each study day. The investigators plan to evaluate 18 participants in this study.

Conditions
Healthy
Being tested
Methylphenidate, Triazolam, Project: EVO, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MethylphenidateDrug

    Also called Ritalin

    Methylphenidate is a central nervous system stimulant. It affects chemicals in the brain and nerves that contribute to hyperactivity and impulse control. Methylphenidate is used to treat attention deficit disorder (ADD), attention deficit hyperactivity disorder (ADHD), and narcolepsy.

  • TriazolamDrug

    Also called Halcion

    Triazolam is a benzodiazepine similar to Valium. Triazolam affects chemicals in the brain that may become unbalanced and cause sleep problems (insomnia). Triazolam is used to treat insomnia (trouble falling or staying asleep).

  • Project: EVOOther

    Also called Cognitive Monitor

    Project: EVO Monitor was designed to incorporate a proprietary multi-tasking assessment into a state-of-the-art mobile video game-like platform, which deploys modern videogame graphics, engaging reward loops, and real-time adaptive mechanics to dynamically personalize difficulty in order to assess the user's ability.

  • PlaceboDrug

    Also called Sugar Pill

    Sugar pill

Study groups in NCT02822937
Study groupRoleWhat they receive
Placebo, Methylphenidate, TriazolamExperimentalThe participants will receive placebo on the first day, 40mg Methylphenidate on the second day, and 0.375mg Triazolam on the third day. All drug administration and cognitive measurement will take place in the clinic under medical staff supervision. During each study day in the clinic, the participants will use Project: EVO Monitor and do a short digit symbol substitution task (DSST) 8 times over the day.
Receives: Drug: Methylphenidate; Drug: Triazolam; Other: Project: EVO; Drug: Placebo
Placebo, Triazolam, MethylphenidateExperimentalThe participants will receive placebo on the first day, 0.375mg Triazolam on the second day, and 40mg Methylphenidate on the third day. All drug administration and cognitive measurement will take place in the clinic under medical staff supervision. During each study day in the clinic, the participants will use Project: EVO Monitor and do a short digit symbol substitution task (DSST) 8 times over the day.
Receives: Drug: Methylphenidate; Drug: Triazolam; Other: Project: EVO; Drug: Placebo
Methylphenidate, Placebo, TriazolamExperimentalThe participants will receive 40mg Methylphenidate on the first day, placebo on the second day, and 0.375mg Triazolam on the third day. All drug administration and cognitive measurement will take place in the clinic under medical staff supervision. During each study day in the clinic, the participants will use Project: EVO Monitor and do a short digit symbol substitution task (DSST) 8 times over the day.
Receives: Drug: Methylphenidate; Drug: Triazolam; Other: Project: EVO; Drug: Placebo
Methylphenidate, Triazolam, PlaceboExperimentalThe participants will receive 40mg Methylphenidate on the first day, 0.375mg Triazolam on the second day, and placebo on the third day. All drug administration and cognitive measurement will take place in the clinic under medical staff supervision. During each study day in the clinic, the participants will use Project: EVO Monitor and do a short digit symbol substitution task (DSST) 8 times over the day.
Receives: Drug: Methylphenidate; Drug: Triazolam; Other: Project: EVO; Drug: Placebo
Triazolam, Placebo, MethylphenidateExperimentalThe participants will receive 0.375mg Triazolam on the first day, placebo on the second day, and 40mg Methylphenidate on the third day. All drug administration and cognitive measurement will take place in the clinic under medical staff supervision. During each study day in the clinic, the participants will use Project: EVO Monitor and do a short digit symbol substitution task (DSST) 8 times over the day.
Receives: Drug: Methylphenidate; Drug: Triazolam; Other: Project: EVO; Drug: Placebo
Triazolam, Methylphenidate, PlaceboExperimentalThe participants will receive 0.375mg Triazolam on the first day, 40mg Methylphenidate on the second day, and placebo on the third day. All drug administration and cognitive measurement will take place in the clinic under medical staff supervision. During each study day in the clinic, the participants will use Project: EVO Monitor and do a short digit symbol substitution task (DSST) 8 times over the day.
Receives: Drug: Methylphenidate; Drug: Triazolam; Other: Project: EVO; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intra-subject sensitivity of Project: EVO cognitive measurements (threshold based) to a cognitive enhancer or a cognitive disruptor at peak drug effects relative to placebo

    Measured: Measurements taken 120 min post drug with a comparison between 3 clinic visits (each with different drug) over 2 weeks

  2. Intra-subject sensitivity of Project: EVO cognitive measurements (reaction time based) to a cognitive enhancer or a cognitive disruptor at peak drug effects relative to placebo

    Measured: Measurements taken 120 min post drug with a comparison between 3 clinic visits (each with different drug) over 2 weeks

Secondary outcomes (4)
  1. Intra-subject sensitivity of Project: EVO cognitive measurements (threshold based) to the cognitive enhancer and cognitive disruptor relative to the placebo measurements using the area-under-the-curve (AUC) analysis

    Measured: Measurements taken predose and 30, 60, 90, 120, 150, 180, and 240 min post drug with a comparison between 3 clinic visits (each with different drug) over 2 weeks

  2. Intra-subject sensitivity of Project: EVO cognitive measurements (reaction time based) to the cognitive enhancer and cognitive disruptor relative to the placebo measurements using the area-under-the-curve (AUC) analysis

    Measured: Measurements taken predose and 30, 60, 90, 120, 150, 180, and 240 min post drug with a comparison between 3 clinic visits (each with different drug) over 2 weeks

  3. Intra-subject sensitivity to Project: EVO cognitive measurements (threshold based) with the onset and decline of the predicted drug effects over the study day, using a quadratic regression model

    Measured: Measurements taken predose and 30, 60, 90, 120, 150, 180, and 240 min post drug with a comparison between 3 clinic visits (each with different drug) over 2 weeks

  4. Intra-subject sensitivity to Project: EVO cognitive measurements (reaction time based) with the onset and decline of the predicted drug effects over the study day, using a quadratic regression model

    Measured: Measurements taken predose and 30, 60, 90, 120, 150, 180, and 240 min post drug with a comparison between 3 clinic visits (each with different drug) over 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2016 (estimated)
  2. Study startJul 2016
  3. Primary completionNov 2016
  4. Study completionNov 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Single group
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02822937
Sponsor's protocol ID
Akili-027
Status last verified
Nov 2016
First submitted
2 Jun 2016
Last updated
7 Nov 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Methylphenidate, Triazolam and Project: EVO in people with Healthy, run by Akili Interactive Labs, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intra-subject sensitivity of Project: EVO cognitive measurements (threshold based) to a cognitive enhancer or a cognitive disruptor at peak drug effects relative to placebo (time frame: Measurements taken 120 min post drug with a comparison between 3 clinic visits (each with different drug) over 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2016.

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